فینگولیمود هیدروکلراید

FINGOLIMOD HYDROCHLORIDE

International non-proprietary name (INN):
FINGOLIMOD HYDROCHLORIDE


Chemical Abstract Index name:
۴-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-
methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-
۴-yl]benzene-1-sulfonamide, monohydrate


CAS Registry No :
162359-56-0

Indication:
Fingolimod is indicated for use in relapsing-remitting multiple sclerosis

Structure

Physical form and appearance : White to off-white powder

Physical state: Solid

Form: Powder

Molecular weight: 343.93 g/mol

Molecular formula: C19H33NO2 . HCl

Identification: IR

Assay (HPLC):99-101 %w/w (on anhydrous basis)

Solubility: Soluble in water, ethanol and DMSO.
Insoluble in acetone and ethyl acetate.

Storage:Keep container tightly closed and store at
-۲۰°C in a freezer.

Technical specification:
(HPLC): 99.5%

Related substance (HPLC)

Individual impurity ≤ .۲۰%

Total impurities ≤ .۵۰%

Method: In-House method as per ICH


Guidelines :